CoFix implant loaner set 48-ls-cofix-imp

GUDID 04260636678929

Paradigm Spine GmbH

Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant

• Primary Device ID: 04260636678929
• NIH Device Record Key: 68931bdd-67ca-41d5-8de5-90477eb9c7f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoFix implant loaner set
• Version Model Number: 48-ls-cofix-imp
• Catalog Number: 48-ls-cofix-imp
• Company DUNS: 537619731
• Company Name: Paradigm Spine GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260636678929 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153302

FDA Product Code

• PEK: Spinous Process Plate

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-29
• Device Publish Date: 2021-06-21

Devices Manufactured by Paradigm Spine GmbH

• 04260636678998 - coflex instrument loaner set: 2023-04-10 instrument loaner set
• 04260636678912 - CoFix instrument loaner set: 2021-06-29
• 04260636678929 - CoFix implant loaner set: 2021-06-29
• 04260636678929 - CoFix implant loaner set: 2021-06-29
• 04260636673467 - SImmetry, Blunt Pin, 3.2mm: 2021-02-02
• 04260636673474 - SImmetry, Impactor: 2021-02-02
• 04260636673481 - SImmetry, Long Pin, 3.2mm: 2021-02-02
• 04260636673498 - SImmetry, Short Pin, 3.2mm: 2021-02-02
• 04260636673504 - SImmetry, Working Cannula: 2021-02-02